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Direct Healthcare Professional Communication (DHPC) on Gavreto▼ (pralsetinib): Increased risk for tuberculosis and measures to minimize this risk

Active substance: pralsetinib

Hoffmann-La Roche in agreement with the European Medicines Agency (EMA) and the Federal Institute for Drugs and Medical Devices (BfArM) would like to inform you that Tuberculosis, mostly extrapulmonary, has been reported in patients receiving pralsetinib. Before starting treatment, patients should be evaluated for active and inactive (“latent”) tuberculosis, as per local recommendations.

Download DHPC / Information letter , Download_VeroeffentlichtAm_EN PDF, 389KB, File is accessible